6 burning questions for Covid-19 vaccine developers headed to the House – STAT

Some drug companies say well have a coronavirus vaccine by the winter. Others say thats an irresponsible prediction. Some promise to forgo profits on a vaccine, but others believe theyre entitled to their monetary due.

Now, lawmakers can force the industry to get its story straight. On Tuesday, executives from five drug companies leading the vaccine race are due at a congressional hearing to talk about their progress in developing a product the entire world desperately needs. Representatives from AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer will appear in front of the House Energy and Commerce Oversight and Investigations Subcommittee.

People weary of the constraints Covid-19 is placing on lives are pinning a lot of hopes on the promises those companies have made, particularly when it comes to when a vaccine might be ready. But there are still looming questions, from who will get a successful vaccine first to how much it might cost.

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Here are six burning questions the panel could pose.

Most of the manufacturers in the hunt for Covid-19 vaccines are making very bold promises about how quickly vaccines will be ready to be deployed and how rapidly theyll be able to produce their vaccines to the kind of scale needed to combat the pandemic. Many are promising tens, even hundreds of millions of doses by early 2021, and some even predict they can scale to the billion-dose range within the next calendar year.

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But in a recent interview with Harvard professor Tsedal Neeley, Merck CEO Ken Frazier warned that these predicted timelines are doing a grave disservice to the public.

For one thing, he said, vaccine development takes time. The fastest vaccine ever developed before now was the mumps vaccine, which took four years.

Cutting corners is a risky business, Frazier suggested: If youre going to use a vaccine in billions of people, you better know what that vaccine does.

Implied in the statement is the risk that any problems that might arise from use of the vaccines would throw fuel on the fire of the anti-vaccine movement, which is already sowing doubts about the safety of these fast-tracked Covid-19 vaccines.

Frazier also warned that giving people the sense a vaccine may be coming soon allows politicians to downplay other tools that can suppress spread of the disease, such as [wearing] the damn masks.

The most pressing question facing the drug industry is how soon it can come up with an effective vaccine. But right behind that is just how much itll cost. And the industry could answer now by committing to a price before a vaccine is approved.

The U.S. government has some leverage for such a demand. With the exception of Pfizer, each of the companies at the table has received substantial federal funding to support its vaccine development. Through the governments Operation Warp Speed project, taxpayers are on the line for more than $3 billion in research support, and the National Institutes of Health is picking up the tab for at least three massive vaccine studies.

So, what does the American public get in exchange? Some manufacturers have promised to sell their vaccines on a not-for-profit basis, at least for the extent of the pandemic. Others have not. Either way, its looking increasingly likely that the novel coronavirus will not simply vanish once the current crisis subsides, meaning there will demand for vaccines for years to come. If thats the case, will companies come to charge whatever the market will bear? Or are they willing to make pricing commitments now?

Since the start of the crisis, news about vaccine trials has made global headlines, moved markets, and seeped into politics. But the process of disseminating that data has been inconsistent. In May, Moderna put out a press release with vague positive language about its early-stage trial, frustrating experts who wanted more. Pfizer chose to upload its data to a preprint server, where scientific papers are posted without peer review, while AstraZeneca is holding out for publication in the Lancet.

A working vaccine is key to restoring anything resembling normalcy, and the public is desperate for information on the process. But without standardizing the current system, the public is left to parse press releases, rumors, and, worst of all, Twitter. Can the companies developing vaccines establish a system whereby the world gets clear, timely updates on their progress?

The second a coronavirus vaccine proves to be safe and effective, the entire world is going to be calling its manufacturer. The U.S. has already moved to secure millions of future doses, and the European Union is reportedly negotiating to do the same, but whats the plan for the world at large?

Scaling up manufacturing is a time-consuming process, meaning drug makers will be dealing with a constrained supply in the months following a vaccines approval. Beyond the wealthy nations that are already locking in bids, how can countries in the developing world ensure they get access?

That may seem like a question beyond the scope of a House hearing, but the U.S. has a public health interest in vaccines being widely available. With an economy deeply reliant on global trade and travel the U.S. will be at risk of another Covid-19 outbreak as long as the virus persists anywhere in the world.

Some manufacturers are suggesting that there may be enough data to warrant emergency use authorizations as soon as October. If that happens, vaccines destined for use in potentially billions of people will be deployed after mere months of human testing.

In the U.S., manufacturers are shielded from liability if a vaccine or drug developed in response to a health emergency causes injuries to people who receive it. That protection comes from the Public Readiness and Emergency Preparedness Act of 2005.

If that protection were not in place, would vaccine manufacturers be willing to roll out vaccines on such a slight evidence base? Will they make them available to countries that dont offer similar protection against liability?

The major manufacturers are all making vaccine at-risk, meaning they are already working to produce at commercial scale, even before they determine whether their vaccine candidate actually works. The goal is to have large amounts available for use as soon as the Food and Drug Administration green-lights a vaccine. If some candidates fail to clear the FDAs bar, that product will be destroyed.

But manufacturing vaccines is a notoriously unpredictable enterprise. During the 2009 H1N1 flu pandemic, the start of mass vaccination was delayed by several months because the manufacturers had trouble scaling up production. The doses arrived as the fall wave of the pandemic was subsiding in the U.S. That happened with a vaccine that manufacturers had decades of experience producing. So it wouldnt be surprising if some of the companies have or will hit snags. In fact, it would probably be surprising if all the projects sailed through on the very ambitious timelines that have been laid out.

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6 burning questions for Covid-19 vaccine developers headed to the House - STAT